摘要
目的考察溶媒种类对注射用埃索美拉唑钠与联用其他药物时的稳定性影响。方法将40 mg注射用埃索美拉唑钠与100 m L的注射用水、0.9%的氯化钠溶液、5%葡萄糖注射液、10%葡萄糖注射液和5%葡萄糖氯化钠注射液配伍,应用HPLC法分别于0、0.5、1、2、4、6、12、24 h测定混合液中埃索美拉唑的含量,定时测定溶液的p H值并观察溶液的颜色/澄明度变化。选用配伍后稳定性最佳的溶媒100 m L配制埃索美拉唑溶液,分别加入10 m L左氧氟沙星注射液、注射用生长抑素、注射用阿莫西林克拉维酸钾、盐酸氨溴索注射液、复方氨基酸射液、甘露醇注射液、注射用果糖二磷酸钠、钠钾镁钙葡萄糖注射液。配伍后观察0、0.5、1、2、4、6、12、24 h溶液的颜色/澄明度变化。结果注射用埃索美拉唑钠溶于0.9%氯化钠注射液24 h后药物浓度、p H值、颜色/澄明度均无明显变化,而溶于注射用水、5%葡萄糖注射液、10%葡萄糖注射液和5%葡萄糖氯化钠注射液后,药物浓度、p H值和颜色/澄明度均有不同程度的变化。埃索美拉唑与左氧氟沙星、阿莫西林钠克拉维酸钾配伍后24 h溶液颜色/澄明度无明显变化;与复方氨基酸和甘露醇注射液配伍后6 h溶液颜色改变;与生长抑素、盐酸氨溴索注射液、注射用果糖二磷酸钠和钠钾镁钙葡萄糖注射液配伍后溶液颜色/澄明度均即刻改变。结论注射用埃索美拉唑钠以0.9%的氯化钠注射液为溶媒时溶液的药物浓度、p H值和颜色/澄明度较稳定;埃索美拉唑与生长抑素、复方氨基酸、甘露醇配伍时溶液颜色/澄明度易发生变化,临床使用时应注意;与盐酸氨溴索注射液、注射用果糖二磷酸钠、钠钾镁钙葡萄糖注射液存在配伍禁忌,临床上应禁用。
Objective To investigate the stability influence of esomeprazole sodium for injection combined pharmacotherapy with different solvents. Methods 40 mg esomeprazole sodium for injection was respectively dissolved in 100 mL water for injection, 0.9% sodium chloride, 5% glucose, 10% glucose, 5% glucose and sodium chloride injection. The concentrations of esomeprazole in different solvents were detected by high performance liquid chromatography at the time 0, 0.5, 1, 2, 4, 6, 12,24 hours. The pH value of the solution was measured regularly and the color/clarity change of the solution was observed. 100mL solution was prepared by solvent with best stability above, then 10 mL levofloxacin injection, somatostatin for injection,amoxicillin and clavulanate potassium, ambroxol hydrochloride injection, compound amino acid injection, mannitol injection,fructose diphosphate sodium for injection, sodium potassium magnesium calcium glucose injection were added. The color/clarity change was observed at 0, 0.5, 1, 2, 4, 6, 12, 24 hours. Results There were no significant changes on content, pH value and color/clarity within 24 h after being mixed with 0.9% sodium chloride. But when the esomeprazole was dissolved in water for injection,5% glucose, 10% glucose, 5% glucose and sodium chloride injection, the content, pH value, and color/clarity all had different degrees of change. Esomeprazole combined with levofloxacin and amoxicillin and clavulanate potassium, the color/clarity had no obvious change after 24 hours. Combined with compound amino acid and mannitol injection, the color was changed after 6 hours, the color and clarity changed immediately when combined with somatostatin, ambroxol hydrochloride injection, fructose diphosphate sodium for injection and sodium potassium magnesium calcium glucose injection. Conclusion The concentration, pH value, color was stable when esomeprazole sodium for injection was dissolved in 0.9% sodium chloride. The color easily changed when esomeprazole combined with compound amino acid and mannitol
作者
李青松
LI Qing-song(Kunshan Chinese medicine hospital, Jiangsu Kunshan 215300, China)
出处
《中国药物警戒》
2016年第10期623-626,共4页
Chinese Journal of Pharmacovigilance
